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Evaluate the Efficacy and Safety of Allogeneic Umbilical Cord Mesenchymal Stem Cells As an Add-On Treatment for Acute ST-elevation Myocardial Infarction (STEMI) Patients

NCT06147986 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2024-09-19

No results posted yet for this study

Summary

This phase IIa study is to identify the efficacy and safety of IC(intracoronary) and IV(Intravenous) administrations of UMSC01 in patients with STEMI . This product is a new cell therapy product for treating AMI and produced by Ever Supreme Bio Technology Co., Ltd in Taiwan. The previous Phase I, open-label, single arm, single center study was conducted to evaluate the safety and to explore the efficacy of UMSC01 in subjects with STEMI via intracoronary administration followed by intravenous infusion. This first-in-human Phase I study of UMSC01 was completed on August 2nd, 2021. Among 8 subjects enrolled, no subjects experienced treatment-related TEAEs.

Conditions

  • ST Elevation Myocardial Infarction

Interventions

BIOLOGICAL

Allogeneic umbilical cord mesenchymal stem cells

UMSC01 cells will be IC infusion followed by IV infusion with 24 months of follow up after treatment.

OTHER

Control group

Standard-of-care for STEMI

Sponsors & Collaborators

  • Ever Supreme Bio Technology Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Woei C Shyu · Ever Supreme Bio Technology Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-24
Primary Completion
2027-06-24
Completion
2027-06-24
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06147986 on ClinicalTrials.gov